Medical Reviewer – Pharmacovigilance Specialist

About the role

ProductLife Group is looking for an experienced Medical Reviewer to join its pharmacovigilance team. The successful candidate will support both clinical trial and post‑marketing safety activities, ensuring high‑quality medical assessments and regulatory compliance.

Key responsibilities

• Review adverse events reported by study sites during clinical phases, assess severity, and recommend actions such as dose adjustments or trial discontinuation.
• Determine SUSAR reportability and perform comprehensive medical assessments of clinical data.
• Draft and present monthly safety reports to clients, including data interpretation and protocol compliance.
• Develop and update training materials in line with GCP and GVP requirements.
• Maintain the medical safety platform, including SOPs, manuals, and related documentation.
• Interact with client medical and clinical teams, providing medical review of spontaneous and literature case reports.
• Support causality assessment, benefit‑risk evaluation, and provide feedback through workshops.
• Participate in audits and inspections as required.

Required profile

• MBBS or MD degree.
• Minimum 5 years of pharmacovigilance medical reviewing experience, preferably with service providers or pharmaceutical companies.
• Strong knowledge of GVP, GCP, FDA, and other drug‑safety regulations.
• Experience with client communications and safety database systems.

Required skills

• Proficiency with Microsoft Office suite.
• Working knowledge of electronic data capture (EDC) systems.
• Experience with safety databases and related documentation.